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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.72 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical Report No. 110
Overall assessment factor (AF):
18
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
67 mg/m³
Explanation for the modification of the dose descriptor starting point:

75 mg/kg bw x (1/0.38) x (50% oral absorption/ 100% inhalation absorption) x (6.7/10)

AF for dose response relationship:
1
Justification:
Default value in ECETOC Technical Report No. 110
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subacute study to chronic exposure. Default value in ECETOC Technical Report No. 110
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into consideration during allometric scaling
AF for other interspecies differences:
1
Justification:
Default valie in ECETOC Technical Report No. 110
AF for intraspecies differences:
3
Justification:
Default value in ECETOC Technical Report No. 110
AF for the quality of the whole database:
1
Justification:
High quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.04 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical Report No. 110
Overall assessment factor (AF):
72
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Assumed dermal absorption is equal to oral absorption as a precautionary measure

AF for dose response relationship:
1
Justification:
Default value in ECETOC Guidance No. 110
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subacute study to chronic exposure value. Default value in ECETOC Guidance No. 110
AF for interspecies differences (allometric scaling):
4
Justification:
Default value in ECETOC Guidance No. 110
AF for other interspecies differences:
1
Justification:
Default value in ECETOC Guidance No. 110
AF for intraspecies differences:
3
Justification:
Default value in ECETOC Guidance No. 110
AF for the quality of the whole database:
1
Justification:
High quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical Report No. 110
Overall assessment factor (AF):
30
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
33 mg/m³
Explanation for the modification of the dose descriptor starting point:

75 * 1/1.15 * 0.5

AF for dose response relationship:
1
Justification:
Default value in ECETOC Technical Report No. 110
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subacute study to chronic value. Default value in ECETOC Technical Report No. 110
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into consideration during allometic scaling
AF for other interspecies differences:
1
Justification:
Default value in ECETOC Technical Report No. 110
AF for intraspecies differences:
5
Justification:
Default value in ECETOC Technical Report No. 110
AF for the quality of the whole database:
1
Justification:
High quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.625 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical Report No. 110
Overall assessment factor (AF):
120
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Assumed dermal absorption is equal to oral absorption as a precautionary measure

AF for dose response relationship:
1
Justification:
Default value in ECETOC Technical Report No.110
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subacute to chronic exposure value. Default value in ECETOC Technical Report No. 110
AF for interspecies differences (allometric scaling):
4
Justification:
Default value in ECETOC Technical Report No. 110
AF for other interspecies differences:
1
Justification:
Default value in ECETOC TEchnical Report No. 110
AF for intraspecies differences:
5
Justification:
Default value in ECETOC Technical Report No. 110
AF for the quality of the whole database:
1
Justification:
High quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.625 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical Report
Overall assessment factor (AF):
120
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default factor in ECETOC Technial Report No. 110
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subacute study to chronic exposure. Default value in ECETOC Technical Report No.110
AF for interspecies differences (allometric scaling):
4
Justification:
Default value in ECETOC Technical Report No.110
AF for other interspecies differences:
1
Justification:
Default value in ECETOC Technical Report No. 110
AF for intraspecies differences:
5
Justification:
Default value in ECETOC Technical Report No. 110
AF for the quality of the whole database:
1
Justification:
High quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population